Search Results

The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.

The DK7786 handpiece is used in combination with the One Series™ Ultra Cartridge to fold and assist in inserting TECNIS® 1-Piece intraocular lenses. ONLY into the capsular bag.

Duckworth & Kent Ltd Model DK7786 Injector

The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.

The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.

The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.

Akreos Single Use Insertion Device, Model AI-28, previously known as Hydroport SI, is validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery. Future IOL models may also by qualified with the Akreos Single Use Insertion Device following fold and recovery validation studies. The device provides a small tubular pathway in which the Akreos Advanced Optics Aspheric Lens can be placed into the eye with one continuous forward motion. The Akreos Single Use Insertion Device consists of two parts: a syringe shaped tube (includes lens loading deck and lens cap) with a plunger, and a transition cell. The Akreos Single Use Insertion Device is a sterile (EtO), disposable plastic device, designed for single use only.

The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.

The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

The Mastel 1 Folder is an ophthalmic surgical device designed for use in inserting a foldable intraocular lens into the eye. The materials, basic scientific concepts, physical properties and intended use of the Mastel 1 Folder are similar to those of the predicate devices. The Mastel 1 Folder Implantation System is comprised of a medical-grade titanium handpiece, a material commonly used in reusable surgical devices. The handpiece rod is designed to accept a single-use cartridge. The handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The handpiece is provided to the customer in a plastic case in a non-sterile state.

The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye. The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.

The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.